Mar 2015

Not all generic drugs are created equal: Why FDA, NIH and Congress need to protect Americans

OP-ED Posted on Fox News

Blockbuster brand-name drugs may make the headlines, but generics rule our nation’s medicine cabinets. Over 80 percent of America’s drug supply is now generic. And the rapid rise of these treatments is partially attributable to the laws governing dispensation: pharmacies are legally allowed to swap in low cost generics for their relatively pricier brand name equivalents.

Such substitution rests on a simple assumption: brand names and their approved generic alternatives are chemically equivalent, operate the same way in the body, possess the same therapeutic powers and run the same health risks.

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FDA Should Follow Europe's Lead on Indian Drug Suspensions

OP-ED ON THEHILL.COM

Europe’s chief drug regulator recently took an unprecedented step and recommended suspending 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. Sabine Julicher, the Head of Unit, Medicinal products said that “falsification of ECGs was performed by at least 10 different individuals over a period of five years, between July 2008 and 2013."

U.S. Federal regulators should follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. In the past, when the US FDA discovered similar fraudulent behavior, it advised patients to continue to take drugs of questionable quality while restricting their further import into the country. This approach provides a fig leaf to the manufacturers in question; they use it to justify their business while the FDA gives them time to take corrective actions. Unfortunately, this approach hasn’t provided the results that the FDA had hoped for. A cursory review of the inspection results of manufacturing facilities in India continue to identify behavior that the FDA calls “data integrity”; in layman’s terms this means that the FDA found the manufacturers continue to try and cheat the agency to secure approvals to sell their products in the US.
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Capitol Hill Briefing - March 18th

Link to Paper

Can We Trust Our Medicines?

The authors of a new working paper will address the ongoing challenges of maintaining high quality standards for America’s drug supply. They will analyze how questionable standards of assessing bioequivalence has cast doubt on the efficacy of many medicines available in the U.S. marketplace, and how dangerous imports are even undermining our safety. They will expose these problems and explore possible solutions.

Wednesday, March 18th, 2015
9:00 - 10:00 A.M.
430 Dirksen Senate Office Building


Panelists
Roger Bate, PhD, American Enterprise Institute Scholar, will chair the panel, present the paper’s findings, and introduce the Safe Medicines Coalition.

Harry Lever, MD, Cardiologist, Cleveland Clinic, will discuss the ongoing problems with medicines he encounters in his medical practice.

Tod Cooperman, MD, Founder of Consumerlab.com, will share his experiences assessing drug quality and bioequivalence.

Preston Mason, PhD Cardiological Expert, Brigham and Women’s Hospital and Harvard Medical School, will discuss his scientific assessments of statin quality.

Dinesh Thakur, Whistleblower in Ranbaxy case and CEO of Medassure Corporation, will discuss how developments between the U.S. and India are affecting drug quality.

To RSVP or request more information, please contact info@safemedicinescoalition.org

FDA should follow Europe’s lead on Indian drug suspensions

Europe’s chief drug regulator recently took an unprecedented step and recommended suspending 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. Sabine Julicher, the Head of Unit, Medicinal products said that “falsification of ECGs was performed by at least 10 different individuals over a period of five years, between
July 2008 and 2013."

U.S. Federal regulators should follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. In the past, when the US FDA discovered similar fraudulent behavior, it advised patients to continue to take drugs of questionable quality while restricting their further import into the country. This approach provides a fig leaf to the manufacturers in question; they use it to justify their business while the FDA gives them time to take corrective actions. Unfortunately, this approach hasn’t provided the results that the FDA had hoped for. A cursory review of the inspection results of manufacturing facilities in India continue to identify behavior that the FDA calls “data integrity”; in layman’s terms this means that the FDA found the manufacturers continue to try and cheat the agency to secure approvals to sell their products in the US.
Read More…
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